Vascular Solutions Recalls SuperCross Microcatheters Due to Surface Contamination
Vascular Solutions, Inc. is recalling SuperCross Microcatheters due to potential surface contamination on aged units discovered during in-house testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a potential for surface contamination, which poses a risk of harm, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Vascular Solutions, Inc. is recalling specific lots of SuperCross Microcatheters. The recall involves 4,731 units of the device, which is intended for use in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature.
The recall was initiated after the company discovered a potential problem during in-house testing. The testing revealed a potential for surface contamination on aged catheters. The affected product was distributed worldwide, including nationwide in the United States and in various international locations.
Consumers and healthcare providers should stop using the affected lots immediately. The specific lot codes are listed in the structured product information. Users should contact Vascular Solutions, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. Product Usage: The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access…
- Manufacturer
- Vascular Solutions, Inc.
- Hazard
- Affected units
- 4,731
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 559450
- 551750
- 552370
- 552761
- 552840
- 552954
- 553267
- 553647
- 553931
- 554269
- 554270
- 554413. 555958
- 557192
- 557824
- 558222
- 558894
- 559827
- 560215
- 551751
- 552371
Distribution
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